提供材料：

1、企业名称与经营范围，注册资本及股东出资比例，股东等身份证明;

2、医疗器械产品注册证书、供应商营业执照、许可证及授权书;

3、质量管理文件等;

4、2个或以上医学专业或相关专业人员证书、身份证明与简历;

5、符合医疗器械经营要求的办公场地及仓库证明; 　6、公司章程、股东会决议等;

7、财务人员身份证和上岗证;8、其它相关材料。

1、提交的材料不同的食药所会有不同的差别，具体以现场核查为准。

2、第二类医疗器械经营备案凭证的申请都需要现场核查，一切情况以现场核查为准。3、医疗器械经营许可的申请，因为申请的类别不同对房屋的经营面积和库房面积要求不尽相同，具体参考《北京市〈医疗器械经营监督管理办法〉实施细则，和现场核查为准

nals; 5. Certificate of office space and warehouse meeting the business requirements of medical device operation; 6. Articles of association, resolutions of shareholders' meeting, etc.; 7. ID card and working card of financial personnel; 8. Other relevant materials. 1. There will be different differences in different food and drug submitted materials, and the specific ones is subject to on-site verification. 2. The application for the business record certificate of category II medical devices requires on-site verification, and all information shall be subject to on-site verification.3. For the application of medical device business license, different categories of the business area and the warehouse area have different requirements. For details, refer to the